1. Field of the Invention
The present invention relates to a fecal management appliance, and to a method and apparatus for introducing the appliance into a body cavity, and more particularly to a fecal management appliance including a tubular element with a balloon carrying distal end formed entirely of soft, compliant material, that includes integral inflation and irrigation lumens, and has a detachable collection receptacle rotatably connected to its proximal end, and to a method and a separate apparatus for introducing the distal end of appliance into a body cavity.
Contamination by fecal matter of open wounds, burns, sutured surgical incisions and the like located proximate the rectum or stoma may be extremely detrimental to patient recovery. Further, healthcare professionals that accidentally come in contact with such waste while caring for patients with those conditions, many of which have severe medical problems requiring intense care, may unintentionally spread infectious diseases.
Accordingly, it is highly desirable to have a system for the management and collection of bowel contents that effectively prevents contamination of the patient and of the healthcare workers providing care to the patient.
2. Description of Prior Art Including Information Disclosed Under 37 CFR 1.97 and 1.98
One such system designed to provide bowel management is marketed by Zassi Medical Evolutions, Inc. of Fernandina Beach, Fla. 32034. The Zassi system consists of an elongated flexible catheter, the proximal end of which is detachably connected to a waste collection bag. The distal end of the catheter is designed to be inserted through the rectum or stoma into the bowel of the patient.
The distal end of the Zassi catheter includes a rigid portion to permit insertion and positioning of the catheter into the bowel. The catheter carries two inflatable balloons, one balloon being situated within the other balloon. The balloons are separately inflatable to block the distal end of the catheter and to seal the catheter to the rectum or stoma, respectively. A separate inflation lumen is provided for each balloon. A third lumen delivers irrigation fluid to the bowel.
Dual balloon systems of this type are known and are disclosed in U.S. Pat. No. 5,569,216 issued Oct. 29, 1996 to Kim, entitled “Multipurpose Colostomy Device Having Balloons On An End Thereof” and in International Publication Number WO 02/26293, published Apr. 4, 2002, and entitled “Improved Colostomy Device.”
Aside from the complexity and cost of the dual balloon system utilized in the Zassi bowel management system, the Zassi apparatus has other drawbacks. Those drawbacks relate to the rigidity of the distal end of the catheter and to the pressure exerted by the balloons upon the adjacent tissue, during and after inflation.
Balloons located on the exterior of the distal end of catheters have been used for many years to hold the catheters in place in a patient's rectum. Such catheter systems are frequently used for enema application but are also used for the collection and directing of fecal material from the rectum to a collection system. Those catheters, sometimes known as Foley catheters, are large versions of devices commonly used for urinary catheterization.
There are many professionals in the medical community who do not approve of the use of inflatable devices in the rectum, as they believe that tissue damage will result from excess pressure exerted on adjacent tissue by the inflated balloon for an extended time. Such tissue necrosis is known to occur when the pressure from the balloon prevents the tissue from being sufficiently profused by blood.
In practice, after the catheter is inserted into the rectum, the balloon is inflated to its full size, regardless of the pressure that it exerts on tissue. Thus, the size of the balloon selected becomes critical. However, since the caregiver has no knowledge of the internal anatomy of the patient, the choice of balloon size is no more than a guess.
The Zassi bowel management system suffers from both of those problems. The distal end of the catheter has a rigid portion to permit insertion and therefore can cause soft tissue damage. The balloon system can be inflated to a pressure that results in prevention of the tissue from being sufficiently profused by blood.